We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Quality of Life Study in Adults With Facial Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00120302
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : January 17, 2008
Information provided by:

Tracking Information
First Submitted Date  ICMJE July 8, 2005
First Posted Date  ICMJE July 15, 2005
Last Update Posted Date January 17, 2008
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
Change in quality of life score between baseline (study start) and week 4.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Changes in patient's quality of life from baseline (study start) to 1 and 2 weeks after the beginning of treatment.
  • Between-treatment comparison of Investigator's Global Assessment (IGA) (face only); Patient's Global Assessment (face only); Pruritus (itch) Severity Assessment (face only).
  • Time from baseline (study start) to clearance of eczema.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Quality of Life Study in Adults With Facial Eczema
Official Title  ICMJE Quality of Life Study in Adults With Facial Eczema
Brief Summary

This study is not being conducted in the US.

The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study.

Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Pimecrolimus
    Pimecrolimus cream 1 %
    Other Name: Elidel
  • Drug: Placebo
    Matching vehicle cream
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Pimecrolimus
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2008)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females aged 18 years or older
  • Active Moderate Facial AE at baseline (Facial IGA score of 3), within 3 days of a deterioration in symptoms that necessitates further treatment.
  • Diagnosis of AE fulfilling the diagnostic criteria of Williams (Williams, et al. 1994) outlined below: *Must have an itchy skin condition plus 3 or more of the following 5 items listed below:

    1. History of involvement of the skin creases such as folds or elbows, behind the knees, fronts of ankles or around the neck;
    2. A personal history of asthma or hay fever;
    3. A history of a general dry skin in the last year;
    4. Visible flexural edema;
    5. Onset under the age of 2
  • Pruritus score of 2 or above at baseline
  • Patients in whom further use of TCS is clinically inappropriate due to:

    • burning, stinging, allergic reaction or other adverse event that prevents the patient from using topical corticosteroids to successfully treat an AE flare on the face;
    • presence of rosacea, telangiectasia, skin atrophy or glaucoma as a result of topical corticosteroid usage on the face;
    • presence of AE on the eyelids Or patients where previous treatment has been unsatisfactory and who would prefer to try an alternative treatment option.
  • Patients who have been informed of the study procedures and have signed the informed consent form approved for the study. (Informed consent should be signed as instructed in ICH-GCP and local regulations).

Exclusion Criteria:

At baseline and throughout the study, females of childbearing potential:

  • Who are pregnant or breast-feeding
  • Who are menstruating, capable of becoming pregnant, and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of study treatment. A negative pregnancy test (urine) for all females of childbearing potential is required at the screening visit. 'Medically approved' contraception may include abstinence at the discretion of the investigator

At baseline and throughout the study, all patients:

  • Who have received phototherapy (e.g. UVB, UVA) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AE within 1 month of Visit 1 (baseline)
  • Who have received systemic corticosteroids (e.g. oral, intravenous, intra-articular, rectal) within 1 month of Visit 1. Patients on a stable maintenance dose of inhaled corticosteroids may participate
  • Who have a known or suspected contact allergic dermatitis
  • Who have received systemic antibiotics within 2 weeks prior to Visit 1.
  • Who have used oral or topical antihistamines for the treatment of Pruritus within 2 weeks prior to visit 1
  • Who have applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus or tacrolimus within 2 weeks prior to Screening
  • Who have used potent or very potent TCS within 4 weeks prior to Visit 1.
  • Who are immunocompromised (e.g. lymphoma, HIV infection/AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
  • Who have a history of poor or no clinical response, or hypersensitivity to topical pimecrolimus cream 1%.
  • Who have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the evaluation.
  • Who have active bacterial (e.g. impetigo), viral (e.g. chicken pox, herpes simplex) or fungal infections (e.g. tinea corporis, intertriginosa)
  • Who have received any investigational drugs within 8 weeks of visit 1, or plan to use any other investigational drugs during the course of this study
  • Who, in the opinion of the investigator, are known to be unreliable, who are non-compliant with medical treatment, or are known to miss appointments
  • Who have abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully in study-related procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00120302
Other Study ID Numbers  ICMJE CASM981CGB02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party External Affairs, Novartis
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Novartis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Novartis
PRS Account Novartis
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP